Full Press Release Details
Reports Third Quarter 2021 Financial Results and Provides Business Update
contract dispute with Cipla resolved, expect to initiate Ph2b study in Q1 2023
treatment of Allergic Bronchopulmonary Aspergillosis (ABPA)
(Acute Migraine Product) IND submission planned for Q1 2022
Ph1 study start anticipated in Q2 2022
(Acute Exacerbation in COPD Product) Ph1b study on track for top-line data in Q1 2022
Mass., November 10, 2021 - Pulmatrix, Inc. (NASDAQ: PULM), a clinical stage biopharmaceutical company developing innovative
inhaled therapies to address serious pulmonary and non-pulmonary disease using its patented iSPERSE technology, today reports
its third quarter 2021 financial results and provides a business update.
resolution of our contract dispute with Cipla is an important milestone which will enable the continued development of Pulmazole globally
with our valued partners," said Ted Raad, Chief Executive Officer of Pulmatrix. "After our successful FDA Type C Meeting
in February, we are excited to resume clinical activities with Pulmazole which has the potential to address the underlying cause of ABPA
while avoiding the side effects of oral antifungals and prolonged steroid treatment. In parallel, we are making steady progress across
our pipeline with top-line data expected in Q1 2022 from our fully enrolled PUR1800 Phase 1b study and we expect the initiation of a
PUR3100 Phase 1study in Q2 2022."
Quarter and Recent Highlights:
| On November 8, 2021, we entered into an amendment (the "Amendment") to our development and commercialization agreement with Cipla (the "Cipla Agreement"), which modifies certain provisions of the Cipla Agreement and resolves the current dispute between us and Cipla regarding each party's respective performance of the Cipla Agreement. Cipla will continue to share 50% of all third-party costs for the development of Pulmazole and will share 40% of our personnel, consulting and overhead costs and will reimburse us for another 10% of such costs upon the timely achievement of development milestones. | ||
| As part of the resolution, the Cipla Agreement was amended to grant Cipla exclusive rights to Cipla territories (India, South Africa, Sri Lanka, Nepal, Iran, Yemen, Myanmar and Algeria) in exchange for 2% royalties under certain circumstances. For the Cipla territories, Cipla will be initiating a clinical program and potential commercialization at its own expense. The rest of the global rights will maintain the equal cost sharing related do development and commercialization costs and equal share of free cash flow from future sales of Pulmazole. | ||
| Pulmatrix has successfully completed a Type C Meeting with the U.S. Food and Drug Administration (FDA) for the further clinical development of Pulmazole and based on feedback from the Type C Meeting, intends to initiate a Phase 2b clinical study of Pulmazole in allergic bronchopulmonary aspergillosis (ABPA) with registration endpoints in Q1 2023 with topline data expected Q2 2024 which may enable a Phase 3 registration study. |
plan to request a Type C meeting with the FDA to further clarify some of the responses in relation to the overall nonclinical and clinical
program. We expect to submit the IND in Q1 2022 and initiate the Phase 1 study in Q2 2022 with top line data expected in Q3 2022. Following
the Phase 1 study, we plan to conduct a randomized placebo-controlled Phase 2 study in patients with migraine to assess the safety and
effectiveness of 2 PUR3100 doses, in which the selection of the 2 doses has been informed by the initial clinical study. We anticipate
that this Phase 2 study will initiate in Q4 2022 and complete in mid 2023.
| Enrollment is complete in the ongoing Phase 1b clinical study of PUR1800 in acute exacerbations in COPD (AECOPD). Study endpoints include safety, tolerability, and exploratory biomarkers to demonstrate target engagement and anti-inflammatory effect. | ||
| PUR1800 Phase 1b top-line data is expected in Q1 2022. |
of September 30, 2021, Pulmatrix had $53.5 million in cash and cash equivalents, compared to $31.7 million for the year ended December
for the third quarter of 2021 was $1.1 million, compared to $4.4 million for the same period in 2020. The revenue for the third quarter
of 2021 was the result of the collaboration and licensing agreements with JJEI.
and development expense was $4.0 million in the third quarter of 2021 compared to $3.9 million for the same period in 2020. The increase
year-over-year was primarily attributable to increased preclinical and manufacturing costs related to the PUR3100 project partially
offset by decreased spend on the PUR1800 program and the Pulmazole Ph2 clinical trial.
and administrative expense was $1.7 million for the third quarter of 2021 compared to $1.8 million for the same period in 2020. The decrease
year-over-year was primarily attributable to decreased employment costs partially offset by increased legal expense.
loss was $8.2 million for the third quarter of 2021 compared to a net loss of $10.6 million for the same period of 2020. The $2.4 million
decrease in net loss year-over-year resulted from a one- time warrant inducement charge of $9.3 million in 2020 which was partially offset
by $3.6 million and $3.3 million that resulted from a goodwill impairment charge and fluctuation in revenue recognition, respectively,
is a clinical stage biopharmaceutical company developing innovative inhaled therapies to address serious pulmonary and non-pulmonary
disease using its patented iSPERSE technology. The Company's proprietary product pipeline includes treatments for serious
lung diseases such as allergic bronchopulmonary aspergillosis ("ABPA"), COPD, and neurologic disorders such as acute migraine.
Pulmatrix's product candidates are based on iSPERSE , its proprietary engineered dry powder delivery platform, which seeks
to improve therapeutic delivery to the lungs by maximizing local concentrations and reducing systemic side effects to improve patient
statements in this press release that are forward-looking and not statements of historical fact are forward-looking statements within
the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements include,
but are not limited to, statements of historical fact, and may be identified by words such as "anticipates," "assumes,"
"believes," "can," "could," "estimates," "expects," "forecasts,"
"guides," "intends," "is confident that", "may," "plans," "seeks,"
"projects," "targets," and "would," and their opposites and similar expressions are intended to identify
forward-looking statements. Such forward-looking statements are based on the beliefs of management as well as assumptions made by and
information currently available to management. Actual results could differ materially from those contemplated by the forward-looking
statements as a result of certain factors, including, but not limited to, the impact of the novel coronavirus (COVID-19) on the Company's
ongoing and planned clinical trials; the geographic, social and economic impact of COVID-19 on the Company's ability to conduct
its business and raise capital in the future when needed; delays in planned clinical trials; the ability to establish that potential
products are efficacious or safe in preclinical or clinical trials; the ability to establish or maintain collaborations on the development
of therapeutic candidates; the ability to obtain appropriate or necessary governmental approvals to market potential products; the ability
to obtain future funding for developmental products and working capital and to obtain such funding on commercially reasonable terms;
the Company's ability to manufacture product candidates on a commercial scale or in collaborations with third parties; changes
in the size and nature of competitors; the ability to retain key executives and scientists; the ability to secure and enforce legal rights
related to the Company's products, including patent protection; and the outcome of the Company's dispute with Cipla regarding
the continued development of Pulmazole. A discussion of these and other factors, including risks and uncertainties with respect to the
Company, is set forth in the Company's filings with the SEC, including its most recent annual report on Form 10-K, as amended,
as may be supplemented or amended by the Company's Quarterly Reports on Form 10-Q. The Company disclaims any intention or obligation
to revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law.
CONSOLIDATED BALANCE SHEETS
thousands, except share and per share data)
| At September 30, | At December 31, | |||||||
| 2021 | 2020 | |||||||
| (unaudited) | ||||||||
| Assets | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 53,491 | $ | 31,657 | ||||
| Accounts receivable | 9 | 84 | ||||||
| Prepaid expenses and other current assets | 938 | 797 | ||||||
| Total current assets | 54,438 | 32,538 | ||||||
| Property and equipment, net | 345 | 361 | ||||||
| Operating lease right-of-use asset | 761 | 1,489 | ||||||
| Long-term restricted cash | 204 | 204 | ||||||
| Goodwill | - | 3,577 | ||||||
| Total assets | $ | 55,748 | $ | 38,169 | ||||
| Liabilities and stockholders' equity | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 875 | $ | 925 | ||||
| Accrued expenses | 1,385 | 2,028 | ||||||
| Operating lease liability | 898 | 1,135 | ||||||
| Deferred revenue | 1,974 | 4,166 | ||||||
| Total current liabilities | 5,132 | 8,254 | ||||||
| Deferred revenue, net of current portion | 5,423 | 6,168 | ||||||
| Operating lease liability, net of current portion | - | 608 | ||||||
| Total liabilities | 10,555 | 15,030 | ||||||
| Stockholders' equity: | ||||||||
| Preferred stock, $0.0001 par value - 500,000 authorized and 0 issued and outstanding at September 30, 2021 and December 31, 2020 | - | - | ||||||
| Common stock, $0.0001 par value - 200,000,000 shares authorized; 56,249,062 and 36,105,097 shares issued and outstanding at September 30, 2021 and December 31, 2020, respectively. | 6 | 4 | ||||||
| Additional paid-in capital | 295,796 | 257,604 | ||||||
| Accumulated deficit | (250,609 | ) | (234,469 | ) | ||||
| Total stockholders' equity | 45,193 | 23,139 | ||||||
| Total liabilities and stockholders' equity | $ | 55,748 | $ | 38,169 |
CONSOLIDATED STATEMENTS OF OPERATIONS
thousands, except share and per share data)
| For the Three Months Ended | For the Nine Months Ended | |||||||||||||||
| September 30, | September 30, | |||||||||||||||
| 2021 | 2020 | 2021 | 2020 | |||||||||||||
| Revenues | $ | 1,069 | $ | 4,372 | $ | 4,713 | $ | 10,634 | ||||||||
| Operating expenses: | ||||||||||||||||
| Research and development | 4,026 | 3,873 | 12,423 | 12,344 | ||||||||||||
| General and administrative | 1,656 | 1,776 | 4,837 | 5,478 | ||||||||||||
| Goodwill impairment | 3,577 | - | 3,577 | - | ||||||||||||
| Total operating expenses | 9,259 | 5,649 | 20,837 | 17,822 | ||||||||||||
| Loss from operations | (8,190 | ) | (1,277 | ) | (16,124 | ) | (7,188 | ) | ||||||||
| Other income (expense): | ||||||||||||||||
| Interest income | 1 | 13 | 6 | 78 | ||||||||||||
| Warrant inducement expense | - | (9,289 | ) | - | (9,289 | ) | ||||||||||
| Other income (expense), net | 5 | - | (22 | ) | (10 | ) | ||||||||||
| Net loss | $ | (8,184 | ) | $ | (10,553 | ) | $ | (16,140 | ) | $ | (16,409 | ) | ||||
| Net loss per share attributable to common stockholders-basic and diluted | $ | (0.15 | ) | $ | (0.31 | ) | $ | (0.30 | ) | $ | (0.62 | ) | ||||
| Weighted average shares of common stock used to compute basic and diluted net loss per share | 56,249,062 | 33,924,499 | 53,081,963 | 26,284,826 |